A Study to Assess the Abuse Potential of Intranasal Cebranopadol

Abuse, Drug Clinical Trial

Official title:

A Double-Blind, Randomized, Crossover Study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453265
• Other study ID #: TRN-228-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Tris Pharma, Inc.
• Contact: Liza Micioni
• Phone: 732-614-8073
• Email: clinicalaffairs[@]trispharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.

Description:

This study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone HCl IR and placebo in recreational opioid users with intranasal experience, a Dose Escalation Phase (Part A) will first be conducted to determine a safe dose for evaluation in the Main Study (Part B).

The Dose Selection Phase (Part A) will consist of 3 phases: Screening, Treatment and Follow-up. Subjects will participate in an outpatient medical screening visit, a 4-day treatment visit and a follow-up phone call.

The Main Study (Part B) will consist of 4 phases: Screening, Qualification, Treatment and Follow-up. Subjects will participate in an outpatient screening visit, a 4-day Qualification Phase, a 30-day Treatment Phase and a follow-up phone call.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Experienced opioid user who meets the following criteria: (1) has used opioids for nontherapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions in the year prior to Screening; (2) has used opioids at least once in the 12 weeks prior to Screening; and (3) self-reported intranasal use of drugs of abuse on at least 3 occasions in the year prior to Screening.

• Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG and vital signs measures (pulse rate, systolic and diastolic blood pressure, respiratory rate and oxygen saturation using pulse oximetry) at Screening.

• Subjects must be willing to comply with the requirements and restrictions of the study.

Key Exclusion Criteria:

• Drug or alcohol dependence in the 12 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).

• Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).

• History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.

• Clinically significant abnormalities in the intranasal cavity (including a deviated septum, perforated nasal septum, rhinorrhea, or excessive sneezing) or any condition that, in the opinion of the investigator, would interfere with the study procedures, data integrity or would compromise the safety of the subject. Subjects with nasal piercings/nose rings will be required to remove them for the duration of their inpatient stay.

Related Conditions & MeSH terms

• Abuse, Drug
• Substance-Related Disorders

Intervention

Drug:
• Cebranopadol- 600 ug
Dose ascending cohorts - Cebranopadol 600 ug single dose
• Cebranopadol- 800ug
Dose ascending cohorts - Cebraopadol 800 ug single dose
• Cebranopadol- 1000ug
Dose ascending cohorts - Cebranopadol 1000 ug single dose
• Treatment A:
Cebranopadol, dose determined in Part A
• Treatment B
Oxycodone HCl IR 40 mg
• Treatment C
Placebo
• Qualification
Oxycodone 40mg
• Qualification
Matching Placebo

Locations

Country	Name	City	State
United States	Ohio Clinical Trials, Inc.	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Tris Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Liking VAS Emax	The primary pharmacodynamic endpoint (Drug Liking VAS Emax) will be evaluated with a linear mixed-effects model, containing treatment, period, sequence and first-order carryover as fixed effects and subject nested within sequence as random effect, using the Modified Completer Population	48 hrs of Tmax for each treatment